As a Technical Writer, you will support the production of customer facing product documentation, including but not limited to: user guides, service manuals, and instructions for use (IFUs). This includes both clinician and patient labeling that accompanies medical device products within the Neuroscience portfolio. You may work on R&D projects such as new product development and released products maintenance.
Typical responsibilities may include:
- Manage all aspects of document development and assist in production release, including draft reviews and formal labeling approvals, coordination of translations, and initiating CO/CA release.
- Revise, edit, and format legacy product documentation as required, including but not limited to user’s guides, service manuals, instructions for providers (IFPs), and instructions for use (IFUs).
- Ensure compliance of labeling with all applicable regulatory/QSR requirements.
- Create, edit, and format documentation as part of the compliance with requirements from the European Union (EU Medical Device Regulation).
- Deliver supporting documentation to the labeling product, including labeling design plans, trace documents, technical reviews and verification deliverables.
- Effectively manage multiple projects, changes in project scope, and shifting priorities to maintain project requirements and ensure deadlines are met.
- Collaborate with departmental and cross-functional peers to ensure proper resolution to questions and issues during the document development process.
- Continually review the document development process to ensure quality in labeling output.
Nice to Have:
- Experience working in a federally regulated environment (FDA)
- Experience with the European Union Medical Device Regulation (EUMDR)
- Familiarity with Quality/CAPA processes and principals
- Self-directed and highly organized
- Ability to manage multiple priorities
- Excellent communication skills
- Advanced writing/editing skills
- Cross-functional collaborative nature
- Product Lifecycle Management software experience
- Medical terminology experience
- Familiar with the principals of neuromodulation
- Product development workflow
Pay Range: $30-42/hr*** Based on experience
